# S2E33 Custom Medical Device Manufacturing, Durability, & the Future of Med Device Tech | Mark A. Farber, MD

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2021-07-30
- Length: 45m
- Episode: 33
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te
- Listen: https://teampipeline.us/custom-medical-device-manufacturing-mark-farber/

## Summary

Dr. Mark Farber, a vascular surgeon at the University of North Carolina and medical device consultant, discusses the challenges of developing custom medical devices for aneurysm treatment. He highlights the difficulty of predicting long-term durability in the harsh mechanical environment of the human body, noting that off-the-shelf devices only fit 25% of patients, necessitating custom manufacturing that can take months. Dr. Farber emphasizes the critical need for engineers to observe clinical procedures to understand the complex, dynamic variables of in vivo testing that lab simulations often miss.

## Chapters

- [0:14](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=14) Introduction: Dr. Mark Farber's Background and Role
- [8:20](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=500) The Evolution of Vascular Devices and Minimally Invasive Surgery
- [10:44](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=644) Durability Challenges: Nitinol Fracture and In Vivo Testing
- [13:18](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=798) The Importance of Clinical Observation for Engineers
- [18:11](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=1091) Long-Term Outcomes: Open Surgery vs. Endovascular Devices
- [21:17](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=1277) Miniaturization Limits and Material Constraints
- [25:35](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=1535) Physician-Sponsored Trials and FDA Regulatory Processes
- [29:26](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=1766) Collaboration Dynamics and Intellectual Property
- [35:50](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te#t=2150) Future of Medical Tech: Biological Imaging and Custom Manufacturing

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- University of North Carolina (company)
- Shell Oil (company)
- Cornell (other)
- FDA (other)
- Nitinol (material)
- Dacron (material)
- Pipeline Design & Engineering (company)

## Related episodes from other shows

- [Challenges related to Home Use Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-10-challenges-related-to-home-use-devices) (Global Medical Device Podcast)
- [A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez](https://hardwarepodcasts.com/podcast/manufacturing-happy-hour/2022-09-27-a-look-inside-medical-device-manufacturing-with-philips-natalia-mendez) (Manufacturing Happy Hour)
- [#461: Why Manufacturing is Part of Product Development with Mike Dolphin](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-22-461-why-manufacturing-is-part-of-product-development-with-mike-dolphin) (Global Medical Device Podcast)
- [#470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-22-470-the-real-cost-of-medtech-innovation-from-idea-to-pre-production-with-lisa-vo) (Global Medical Device Podcast)
- [005 - “Compassionate Product Development” with Cameron Jones](https://hardwarepodcasts.com/podcast/lets-combinate/2021-11-03-005-compassionate-product-development-with-cameron-jones) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/being-an-engineer/2021-07-30-s2e33-custom-medical-device-manufacturing-durability-the-future-of-med-device-te. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Being an Engineer.